- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02490579
Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples
20 mai 2016 mis à jour par: Michelle H. Moniz, University of Michigan
The primary purpose of this study is to assess the responses of pregnant women and their social network to six videos about health in pregnancy.
Our goal is to assess a) acceptability and b) understanding of core messages about healthy eating, exercise and weight gain during pregnancy.
We will also assess c) non-clinical sources of health information during pregnancy.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Many women engage in suboptimal lifestyle behaviors during pregnancy.
Many women do not realize that unhealthy diet, exercise and weight gain behaviors can be dangerous for their pregnancy and have harmful long-term consequences for their baby.
There is great need for strategies to promote accurate knowledge about healthy behaviors during pregnancy.
The purpose of this study is to assess responses to a brief (<1minute) video about healthy behaviors during pregnancy.
The study sample will include pregnant women and members of their social network.
Participants will be asked to watch a brief video and complete an anonymous online survey measuring their response to the video, and their basic demographics.
The surveys will also assess how family and friends impact pregnant women's health behaviors.
Online surveys are entirely anonymous.
We will recruit pregnant participants from two sources: the University of Michigan Health System's prenatal clinics and a social media website (Facebook).
Type d'étude
Observationnel
Inscription (Réel)
1670
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 50 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Women recruited via either the social media, clinical, or online approach will be eligible for participation if they are aged 18 years and older, pregnant, and English-speaking.
Women will be excluded if they deny being currently pregnant, do not identify as living in the US and aged 18 years or older, or if they report having previously participated in the study.
The Qualtrics survey will automatically conclude if potential participants provide answers to screening questions that deem them ineligible.
Participants will not be excluded based on racial-ethnic groups.
Males will be excluded, as this is a study involving pregnant women.
La description
Inclusion Criteria:
- Women
- Currently Pregnant
- Age 18 or over
- English-speaking
Exclusion Criteria:
- Deny being currently pregnant
- Do not identify as living in the US and aged 18 years or older
- Report having previously participated in the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Facebook Survey Group
During June, 2015, approximately 1200 women will be recruited through Facebook advertisements targeted at English-speaking women age 18-50 years living in the United States.
Advertisements will contain 3 key features: an image, a caption, and "ad copy" followed by a link to the survey website.
Individuals who click on the study link in the advertisement will be redirected to the study's Qualtrics web page where they will take a 15 web-page, multiple choice survey developed by the research team.
The survey covers these domains: reaction to video, understanding of core message, self-efficacy around lifestyle behaviors, attitudes, beliefs and intentions regarding vaccination during pregnancy, key health information sources during pregnancy, and demographics.
|
Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) self-efficacy about healthy eating, exercise and weight gain during pregnancy.
|
|
Clinical Survey Group
During June-August, 2015, approximately 500 women will be recruited at routine obstetric visits to the University of Michigan's outpatient clinics.
Women who check in for an Ob appointment will be offered the opportunity to participate in an anonymous online survey.
Individuals who express interest in participating will be provided with a laptop and headphones and directed to the survey Qualtrics site where they will take a 15 web-page, multiple choice survey developed by the research team.
The survey covers these domains: reaction to video, understanding of core message, self-efficacy around lifestyle behaviors, attitudes, beliefs and intentions regarding vaccination during pregnancy, key health information sources during pregnancy, and demographics.
|
Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) who in her social network she turns to for non-clinical health advice and what kinds of advice she gotten in the past.
|
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Social Network Group
Once a pregnant participant completes the survey, she will be asked to provide her email address.
If she is willing to do so, Qualtrics will automatically send her an email containing a weblink to the survey for her social network.
She can then provide this link to 1 or 2 social network members that she feels influence her health behaviors during pregnancy.
These members are asked similar questions about their response to the video, as well as some additional questions about how they advise their pregnant person about different health topics.
It is necessary to provide a unique weblink to her, so that the survey responses from the pregnant woman and her unique social network members can be linked.
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Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) how they advise their pregnant friend about different health topics.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Composite acceptability score (continuous variable)
Délai: 15 minutes
|
Participants will be asked questions about their reaction to the video.
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15 minutes
|
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Understanding of core messages (free text item; categorical items)
Délai: 15 minutes
|
Trained research assistants will review answers to questions regarding diet, exercise and weight gain in pregnancy to determine whether individuals understood/did not understand the core message.
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15 minutes
|
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Self-efficacy (continuous scale; Facebook group only)
Délai: 15 minutes
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Participants will answer questions about self-efficacy regarding weight gain, exercise and diet.
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15 minutes
|
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Sources of information about health during pregnancy (categorical variable; clinic and social network groups only)
Délai: 15 minutes
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Participants will answer questions about what sources of health information are provided by social network contacts during pregnancy.
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15 minutes
|
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Content of health information from interpersonal sources during pregnancy (free text variable; clinic and social network groups only)
Délai: 15 minutes
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Trained research assistants will review answers to questions about the types of health information and advice are provided by social network contacts during pregnancy.
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15 minutes
|
|
Perceived impact of interpersonal health advice on health behaviors during pregnancy (categorical and free text variables; clinic and social network groups only)
Délai: 15 minutes
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Participants answer questions about the impact the health information and advice they receive from social network contacts during pregnancy has on their behavior.
|
15 minutes
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Michelle H. Moniz, MD, University of Michigan
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2015
Achèvement primaire (Réel)
1 septembre 2015
Achèvement de l'étude (Réel)
1 novembre 2015
Dates d'inscription aux études
Première soumission
29 juin 2015
Première soumission répondant aux critères de contrôle qualité
6 juillet 2015
Première publication (Estimation)
7 juillet 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
23 mai 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2016
Dernière vérification
1 mai 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUM00101358
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .